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Pilot Testing a Novel Approach to Pediatric Obesity Treatment

NCT06755827 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-15

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if an emotion regulation and self-monitoring intervention can help treat overweight and obesity in teens. The main question it aims to answer is:

* Does emotion regulation and self-monitoring help reduce biases in teens with overweight and obesity?
* Do changes in biases relate to changes in health functioning and health behavior?

Researchers will compare the intervention to the provision of educational handouts about overweight and obesity to see if the intervention is more effective.

Participants will:

* Complete self-report questionnaires, an fMRI scan, and have their blood drawn
* Received educational handouts or attend weekly telehealth group sessions weekly for four weeks and be asked to self-monitor their mood and behavior between sessions
* Return to complete the same questionnaires, fMRI and blood draw procedures

Conditions

  • Overweight Adolescents
  • Obese Adolescents

Interventions

BEHAVIORAL

Emotion regulation and self-monitoring to treat pediatric obesity

Participants will attend telehealth group sessions once weekly and be asked to self-monitor their mood and health behaviors daily between sessions.

OTHER

Psychoeducation

Participants who are randomized to the control group will receive an online, one-time, self-led psychoeducation program with information about current daily sleep, diet, and physical activity recommendations (e.g., information about sleep hygiene, the food pyramid, and recommendations for 60 minutes of moderate-to-vigorous physical activity daily).

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Pennington Biomedical Research Center

    collaborator OTHER

  • Texas Tech University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-24
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06755827 on ClinicalTrials.gov